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OpenTrials
Completed

NCT Number: NCT04220359

Early Identification of Clinical Deterioration Using a Wearable Monitoring Device

This study aims to provide myriad of physiological parameters in patients admitted in an internal medicine department, and which are defined as being in an increased risk of clinical deterioration within the first 72-hours after admission. The investigators will also conduct a retrospective comparison between physiological changes in patients who did deteriorate to those who did not. This will form the basis for the development of an algorithm for early prediction and warning of physiological and clinical deterioration during the first 72-hours of admission.

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Key information

Conditions

Clinical Deterioration Disease Attributes Disease Progression Hemodynamic Instability Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Sheba Medical Center, Tel Hashomer

Ramat Gan, 52621, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 18 years old and above admitted to the internal medicine department
  • On admission, the primary investigator assess their risk to deteriorate during the first 72 hours after admission as reasonably high
  • The patient is assigned to a "monitoring bed" within the department
  • The patient has signed an informed consent form

Exclusion criteria

  • Lack of informed consent
  • It is known in advance that the patient cannot take part in the study for a 72-hours period (e.g. a patient that will be taken to surgery within the next 24 hours)
  • Technical inability to attach the Biobeat patch (BB-613PW) to the patients chest

Treatment and study plan

Non-invasive monitoring

Device

Prospective monitoring with retrospective big-data analysis

Other names: BB-613PW

Primary outcomes

  1. Monitoring blood pressure changes in high-risk patients

    Time frame: 72 hours per individual

    The investigators will record blood pressure measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

Secondary outcomes

  1. Monitoring early heart rate changes in high-risk patients

    Time frame: 72 hours per individual

    The investigators will record heart rate using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

  2. Monitoring respiratory rate changes in high-risk patients

    Time frame: 72 hours per individual

    The investigators will record respiratory rate using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

  3. Monitoring blood oxygen saturation changes in high-risk patients

    Time frame: 72 hours per individual

    The investigators will record blood oxygen saturation using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

  4. Monitoring stroke volume changes in high-risk patients

    Time frame: 72 hours per individual

    The investigators will record stroke volume measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

  5. Monitoring cardiac output changes in high-risk patients

    Time frame: 72 hours per individual

    The investigators will record cardiac output measurements using a non-invasive wireless monitoring device working continuously for 72 hours in high-risk patients.

Sponsors and collaborators

Lead sponsor

Biobeat Technologies Ltd.

Industry

Collaborators

  • Sheba Medical Center

Registry information

Official study title

Early Identification of Hospitalized Patients at High-risk for Clinical Deterioration During the First 72-hours in an Internal Medicine Department. A Prospective, Continuous, Physiologic Big-data-analysis Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2020
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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